Regulatory Landscape For Drug Registration Requirements and Procedure In China: An Emerging Pharmaceutical Market

Abstract

China has been into focus for foreign pharmaceutical investors since last few decades, and this may be attributed to many factors as consumer spending on medicine in China is inexorably rising as a result of rising living standards, increased health awareness, and a growing need for medical care due to an ageing population, government medical insurance coverages, rise in the essential drug list pertaining to some of the chronic western diseases like diabetes, hypertension, depression, cancer hence filling of western country drugs would be an added benefit. China undoubtably Tier 1 emerging country amongst BRIC and MIST the market is steadily rising and is the world's second-largest pharmaceutical market, while the United States still stands first being more old and mature market yet more saturated now as more and more investors are now gaining the market-shares. The Thesis revolves around China drug regulations for imported drugs under 5.1 and 5.2 drugs, is describes the regulatory pathways and checklists of documents for BE Notification and documents to be attached on the dossier. Moreover, the role of the Chinese responsible agent (CRA) has been described and duties of NMPA, NIFDC are enlisted. Later, general chapters of tablets and capsules are differentiated as the matter of fact that the drug products have to be ultimately be compliant to Chinese Pharmacopoeia else, superior. Emphasis has been put on differentiating the US and China CMC Module 3 to which after successful entry into Chinese markets the post approval changes are also briefed and classified under minor moderate and major based on the impact on quality of drug products. The Thesis assists the imminent pharmaceutical market seeker to venture successfully into this emerging market.